Implant with composite coating

ABSTRACT

Systems and methods are described for implants with composite coatings to promote tissue in-growth and/or on-growth. An implant includes: a substrate; a structured surface formed on at least a portion of the substrate; and a biocompatible coating deposited on at least a fraction of the structured surface. The systems and methods provide advantages in that the implant has good biocompatibility while the biocompatible coating has good strength.

REFERENCE TO PRIOR PATENT APPLICATIONS

This patent application is a continuation of prior U.S. patentapplication Ser. No. 09/901,310, filed Jul. 9, 2001, now U.S. Pat. No.7,105,030, by Alfred S. Despres III et al. for IMPLANT WITH COMPOSITECOATING, which patent application is in turn a continuation of priorU.S. patent application Ser. No. 09/079,502, filed May 14, 1998, nowU.S. Pat. No. 6,261,322, by Alfred S. Despres III et al. for IMPLANTWITH COMPOSITE COATING.

The above-identified patent applications are hereby incorporated hereinby reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The invention relates generally to the field of in vivo implants. Moreparticularly, preferred embodiments of the invention are directed to anorthopedic prosthesis having a composite coating to promote tissuein-growth and/or tissue on-growth.

2. Discussion of the Related Art

Prior art implants are known to those skilled in the art. For example,conventional implants are typically composed of stainless steel,cobalt-chrome, or titanium alloy.

A problem with this technology has been that the best substratematerials are not the best materials to be in contact with livingtissue. Therefore, what is required is a solution that can provide abiocompatible coating on a substrate.

One approach in an attempt to solve the above-discussed problemsinvolves simply coating an implant substrate with a biocompatiblematerial. However, a disadvantage of this approach is that biocompatiblematerials are often soft or brittle.

Another disadvantage of this approach has been relatively high costand/or technical complexity. Therefore, what is also needed is asolution that meets the above-discussed requirements in a more simpleand cost effective manner.

Heretofore, the requirements of good substrate properties, and goodcoating properties referred to above have not been fully met incombination. What is needed is a solution that simultaneously addressesboth of these requirements.

SUMMARY OF THE INVENTION

A primary object of the invention is to provide implants with acomposite coating to promote tissue in-growth and/or tissue on-growth.Another primary object of the invention is to provide a composition thatcan be used as the composite coating. Another primary object of theinvention is to provide implants having a composite coating that islocated only on surface areas of the implant that are to be fixed withtissue in-growth and/or on-growth for stability. Another primary objectof the invention is to provide methods of making the orthopedic implant.

In accordance with these objects, there is a particular need for animplant with a composite coating. Thus, it is rendered possible tosimultaneously satisfy the above-discussed requirements of goodsubstrate properties and good biocompatible coating properties, which,in the case of the prior art, are mutually contradicting and cannot beeasily satisfied.

A first aspect of the invention is implemented in an embodiment that isbased on an implant, comprising: a substrate; a structured surfacedefined by at least a portion of the substrate; and a biocompatiblecoating deposited on at least a fraction of the structured surface. Asecond aspect of the invention is implemented in an embodiment that isbased on a composition for an implant, comprising: a biocompatiblematerial coated on a structured surface defined by a substrate. A thirdaspect of the invention is implemented in an embodiment that is based onan implant, comprising: a substrate; a structured surface defined by aportion of the substrate; and a biocompatible coating deposited on atleast a fraction of the structured surface, wherein the portion of thesubstrate is to be fixed with tissue in-growth and/or on-growth forstability. A fourth aspect of the invention is implemented in anembodiment that is based on a method of forming a composite coating,comprising: depositing a biocompatible coating on a structured surfacedefined by at least a portion of a surface area of a substrate.

These, and other, objects and aspects of the invention will be betterappreciated and understood when considered in conjunction with thefollowing description and the accompanying drawings. It should beunderstood, however, that the following description, while indicatingpreferred embodiments of the invention and numerous specific detailsthereof, is given by way of illustration and not of limitation. Manychanges and modifications may be made within the scope of the inventionwithout departing from the spirit thereof, and the invention includesall such modifications.

BRIEF DESCRIPTION OF THE DRAWINGS

A clear conception of the advantages and features constituting theinvention, and of the components and operation of model systems providedwith the invention, will become more readily apparent by referring tothe exemplary, and therefore nonlimiting, embodiments illustrated in thedrawings accompanying and forming a part of this specification, whereinlike reference characters (if they occur in more than one view)designate the same parts. It should be noted that the featuresillustrated in the drawings are not necessarily drawn to scale.

FIG. 1 illustrates a schematic perspective view of an orthopedicimplant, representing an embodiment of the invention.

FIG. 2 illustrates a schematic perspective view of an orthopedicimplant, representing an embodiment of the invention.

FIGS. 3 a-3 b illustrate micrograph views of a physical vapor depositedcoating of titanium on a structured surface of cobalt-chrome alloy,representing an embodiment of the invention.

FIG. 4 illustrates a schematic view of a coating on a porous structuredsurface, representing an embodiment of the invention.

FIG. 5 illustrates a schematic view of an apparatus and process forcoating a structured surface, representing an embodiment of theinvention.

FIGS. 6 a-6 b illustrate scanning electron micrographs of abiocompatible coating on CoCrMo particles after an electrochemical test,representing an embodiment of the invention.

FIGS. 7 a-7 d illustrate scanning electron micrographs of CoCrMoparticles without the biocompatible coating after the electrochemicaltest, representing an embodiment of the invention.

FIGS. 8 a-8 b illustrate SEM of CoCrMo particles without coating beforetest, representing an embodiment of the invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

The invention and the various features and advantageous details thereofare explained more fully with reference to the nonlimiting embodimentsthat are illustrated in the accompanying drawings and detailed in thefollowing description. Descriptions of well known components andprocessing techniques are omitted so as not to unnecessarily obscure theinvention in detail.

The context of the invention is providing an implant to be positioned invivo during surgery, especially orthopedic surgery to replace a joint,such as, for example, a knee joint or a hip joint. Thus, the implant canbe used in a method for orthopedic surgery that includes surgicallypositioning the implant within a vertebrate in need thereof. If bonegrowth is facilitated, the implant can be termed part of anosteoconductive process that includes contacting a bone under in vivoconditions with the implant.

Referring to the drawings, a detailed description of preferredembodiments of the invention is provided with respect to FIGS. 1 through5. The invention is not limited to the specific embodiments illustratedin FIGS. 1-5.

Referring now to FIG. 1, a component 110 of an artificial knee joint isdepicted. The component 110 includes a bearing surface 120 and a tissuefixation surface 130. The bearing surface 120 is for sliding. The tissuefixation surface 130 is for tissue in-growth and/or tissue on-growth.The tissue fixation surface 130 can be a coating that is deposited on atleast a fraction of a structured surface that is defined by, or formedon, or composed by at least a portion of a substrate.

The substrate can be composed, or formed, of, for example,carbon-composite, stainless steel, cobalt-chromium, titanium alloy,tantalum, and/or ceramic, and combinations thereof. The structuredsurface can be defined by, or composed of, or formed of a material thatincludes a plurality of particles that are sintered together to form acontinuous porous phase. Alternatively, the structured surface can beprepared by at least one method selected from the group consisting offlame spraying, acid etching, grit blasting, casting-in, forging-in,laser texturing, and micromachining.

The coating should be a biocompatible coating. The biocompatible coatingcan include one, or more, of titanium, tantalum, carbon, calciumphosphate, zirconium, niobium, hafnium, hydroxyapatite, tissue in-growthand/or on-growth facilitating proteins, and combinations thereof. Ifcarbon is used, it can optionally be diamond-like carbon, pyrolyticcarbon, amorphous diamond-like carbon, and combinations thereof.

It can be advantageous that the coating be more biocompatible than thestructured surface. Similarly, it can be advantageous that the coatingbe more biocompatible than the substrate. One aspect, albeit optional,of biocompatibility is softness. It can be advantageous that the coatingbe softer than the structured surface. Similarly, it can be advantageousthat the coating be softer than the substrate. Although the preferredembodiment shown in FIG. 1 includes a coating located on specificportions of the substrate, it is within the level of ordinary skill inthe art after having knowledge of the invention disclosed herein to coatany surface(s) of the substrate.

Referring now to FIG. 2, an artificial hip joint is depicted. The hipjoint includes a femoral head 210 and distal portion 220. The femoralhead 210 includes a joint motion surface 230 for bearing and sliding.The distal portion 220 includes a taper connection 240, a tissuefixation surface 250, and a distal stem 260. The tissue fixation surface250 can be a coating that is deposited on at least a fraction of astructured surface that is defined by, or formed on, or composed by atleast a portion of a substrate. As noted above, the coating should be abiocompatible coating. The biocompatible coating can includemulti-layers. These multi-layers can be nano-layers. Although thepreferred embodiment shown in FIG. 2 includes the coating located on aspecific portion of the substrate, it is within the level of ordinaryskill in the art after having knowledge of the invention disclosedherein to coat any surface(s) of the substrate.

Referring now to FIGS. 3 a-3 b, two images of a structured surfacecoated according to the invention are depicted. FIGS. 3 a-3 b are twoimages of the same sample acquired at different locations. FIG. 3 aillustrates a coating 310 on a structured surface 320 at an outermostlocation. The structure surface 320 is defined by a sintered layerhaving interconnected porosity. The thickness of the coating 310 isapproximately 10.78 microns at this outermost location of the structuredsurface 320. FIG. 3 b illustrates the coating 310 on the structuredsurface 320 at an innermost location. The thickness of the coating isapproximately 2.0 microns at this innermost location of the structuredsurface 320.

Still referring to FIGS. 3 a-3 b, the coating 310 is adhered to thestructured surface 320. In this particular embodiment, the coating 310is composed of a first material that includes titanium. The coating ispreferably a biocompatible coating. In this particular embodiment, thestructured surface 320 is defined by a second material that includescobalt and chrome. In this particular embodiment, the structured surfacewas conditioned by cathodic arc ion plating of titanium before thecoating 310 was deposited using the same apparatus used to effect theion plating. In this particular embodiment, the average thickness of thecoating 310 is approximately 10.78 microns. If the structured surface320 includes crevices and/or undercuts 330, the biocompatible materialthat composes the coating 310 can coat the crevices and/or undercuts 330in the structured surface.

It can be advantageous if the biocompatible material conforms to thecrevices and/or undercuts and thereby defines a textured (e.g., rough)topology at the upper surface of the biocompatible material. This isadvantageous because such a topology gives tissue a better hold viatissue in-growth and/or on-growth. Further, if there are pores in and/orbeneath the structured surface, the biocompatible material can coat thepores. It can be advantageous if the biocompatible material coatsinterconnected pores located beneath the structured surface and therebydefine voids (pores) and/or interconnected pores in which tissuein-growth and/or on-growth can occur.

The effect of cathodic arc ion plating with a high bias voltage is tocause an intermixing of titanium into the cobalt-chrome substrate due tohigh ion energies. It can be appreciated that there is aninter-penetration of the coating material into the structured surfacematerial between the interface and the bulk of the material thatcomposes the structured surface. Specifically, the amount of coatingmaterial that composes the substrate that defines the structured surfacedecreases as the depth from the interface increases. When the biasvoltage is increased, the inter-penetration depth increases. The depthof this intermixing can range from approximately 0.5 nm to approximately500 nm, preferably approximately 50 nm to approximately 100 nm. When thebias voltage is sufficient, substantial inter-penetration occurs. Thisresult is advantageous because the inter-penetration improves theadhesion of the coating to the structured surface, thereby minimizingflaking, peeling, and other disruptions of the coating. This is veryimportant for at least the following two reasons. First, the coatingwill be subject to tissue in-growth and/or on-growth and, therefore, canbe subject to dynamic loading from adjacent tissue structures, such as,for example, bones. By improving the adhesion, the coating is betterable to withstand loading. Second, the implant may be expected to remainin vivo for many years and it is highly desirable that all of theimplant remain fixed in place. By improving the adhesion of the coatingto the structured surface, the long term stability of the coating isenhanced.

Referring now to FIG. 4, a porous structured surface 410 with a coating420 is depicted. The coating 420 includes titanium and can be depositedvia physical vapor deposition with a gas, preferably an inert gas, suchas, for example, argon and/or helium. It can be advantageous to useargon as the gas because it is inert and has a relatively high atomicweight. Significantly, the coating 420 covers portions of a structuredsurface defined by an interconnected pore 430 that is hidden fromline-of-sight deposition (i.e., the pore 430 cannot be seen from thepoint of view of the deposition source). The structured surface is alsodefined by a plurality of particles covering a substrate 440 (i.e., thestructured surface is defined by the interface between the substrate 440and the plurality of particles). Nevertheless, the surface defined bythe interconnected pore 430 is coated and provides an area for tissuein-growth and/or on-growth because an inert gas is present in thedeposition chamber while the coating 420 is being applied. Although thepreferred embodiment shown in FIG. 4 includes the coating of the surfacedefined by the interconnected pore 430, it is within the level ofordinary skill in the art after having knowledge of the inventiondisclosed herein to coat any undercut, or vertical, or line-of-sighthidden surface area.

FIG. 4 demonstrates substantially improved results that are unexpected.Specifically, the coating of internal pores demonstrates the significantunexpected advantageous result that when an inert gas is present duringthe deposition process, the coating is deposited on line-of-sight hiddensurfaces (e.g. interconnected pores). It can be appreciated that thestructured surface 410 is coated because the exterior of the particlesappears rough. Normally, in the case of an uncoated particle, theperimeter would be smooth and more nearly circular. The roughness is thecoating. This result is advantageous because it significantly improvesadhesion of the surrounding tissue to the implant. Adhesion issignificantly improved because tissue on-growth and/or in-growth cantake place on undercuts, crevices, cul de sacs, conduits, caves,tunnels, and interconnected pores that are hidden from line-of-sightdeposition, thereby significantly improving the strength of theconnection between the surrounding tissue and the implant. The strengthof the connection is significantly improved because the tissue growsinto the undercuts, crevices, cul de sacs, conduits, caves, tunnels, andinterconnected pores creating a tissue structure that interlocks withthe structured surface on a macroscopic level. It can be advantageous ifthe coating covers a continuous length of a void structure (e.g.,undercuts, crevices, cul de sacs, conduits, caves, tunnels,interconnected pores, etc.) that is open to adjacent tissue in at leasttwo places. For example, if the tissue grows through a tunnel, thestrength of the connection will be based not only on the interfaceadhesion between the wall of the tunnel and the tissue, but also on theinherent mechanical strength of the loop of tissue that is routedthrough the tunnel.

The particular manufacturing process used for depositing the coatingshould be inexpensive and reproducible. Conveniently, the deposition ofthe coating can be carried out by using any vapor deposition method.Vapor deposition methods include chemical vapor deposition (CVD) (e.g.,plasma assisted CVD) and physical vapor deposition (PVD) (e.g., arcevaporation, e-beam, molten pool, sputtering, evaporative ion plating,and cathodic arc ion plating). It is preferred that the process be aphysical vapor deposition. For the manufacturing operation, it ismoreover an advantage to employ an arc evaporation physical vapordeposition method.

FIG. 5 depicts an arc evaporation physical vapor deposition apparatusand method for coating a structured surface on a substrate. A watercooled chamber 510 functions as an anode. A vacuum pump 520 and aconduit 530 for a neutral gas and a reactive gas are connected to thechamber 510. The chamber includes a plurality of evaporators 540 thatfunction as cathodes. Each of the evaporators includes a source of amaterial 545 from which the coating is to be formed (e.g., titanium). Anarc power supply 550 can be connected to each of the plurality ofevaporators 540 (only a single connection is shown in FIG. 5). Each ofthe evaporators 540 can generate a plasma 560 that includes a highnumber of ions together with electrons and neutral vapor atoms. (Itshould be noted that the plasma 560 is represented schematically forclarity.) The plasma 560 impinges upon a substrate 570 that is connectedto a bias (−) power supply. By increasing the bias, the ions areaccelerated toward the substrate more rapidly. The apparatus can alsoinclude one, or more, structures to steer and/or filter the plasma suchas, for example internal and/or external magnets.

Still referring to FIG. 5, the substrate 570 includes a structuredsurface (not shown) onto which the coating can be deposited. Portions ofthe substrate that are not to be coated can be masked with a maskmaterial that can be removed after the deposition of the coating isfinished. In general, the coating can be formed by any thin filmtechnique. Thin film techniques include physical vapor deposition andchemical vapor deposition, and combinations thereof.

Still referring to FIG. 5, the method of using the illustrated apparatusbegins by loading the substrate 570 into the chamber 510. A vacuum isthen created in the chamber 510 using the vacuum pump 520. A test forleaks is then conducted. A conditioning and heating subprocess can thenbe performed. One reason to conduct this subprocess is to heat andremove any oxides from the structured surface. This subprocess can bebased on radiant heating. This subprocess can also be based on glowdischarge with a high bias voltage to effect an ion bombardment by agas, or gas mixture. This subprocess can also be based on ionbombardment with the material from which the coating is to be formed(e.g., titanium) with a high bias voltage (e.g., from approximately 1000to approximately 1500 volts). This latter technique causes anintermixing of the coating material (e.g., titanium) into the materialthat defines the structured surface (e.g., CoCr). After the conclusionof the subprocess, the coating is applied. The bias voltage is loweredto deposit and build up the coating. By adding a gas, preferably aninert gas, such as, for example, argon or helium (most preferablyargon), full coverage of undercuts and full coverage within porestructures can be obtained.

While not being limited to any particular theory, it is believed thatthe presence of the gas reduces the average velocity and increases thescattering of the coating vapor as it moves from the cathode to thestructured surface, thereby allowing better migration of the coatingvapor inside the undercuts, crevices, cul de sacs, conduits, caves,tunnels, interconnected pores, etc., before the vapor is deposited(i.e., fixed) on the structured surface. This relationship may be due toan increase in scattered vector components representing the speed anddirection of the vapor molecules due to collisions between the vapormolecules and the gas molecules, with a corresponding decrease in themagnitude of a primary vector representing the average speed andvelocity of all the vapor molecules.

Still referring to FIG. 5, the process temperature can range fromapproximately 500 to approximately 900 deg. F. The operating pressureduring radiant heating can range from approximately 1.0 millitorr toapproximately 0.01 millitorr. The operating pressure during the bombardphase (e.g., titanium without any dampening gas) can range fromapproximately 10.0 millitorr to approximately 0.001 millitorr. Theoperating pressure during the coating phase (e.g., titanium withoptional dampening gas) can range from approximately less than 1millitorr to approximately 100 millitorr. The arc voltage can range fromapproximately 10 to approximately 100 volts/evaporator. The bias voltagecan range from approximately 1000 to approximately 1500 volts duringbombardment, and from approximately 10 to approximately 500 volts duringcoating.

However, the particular manufacturing process used for depositing thecoating is not essential to the invention as long as it provides thedescribed biocompatible coating. Normally those who make or use theinvention will select the manufacturing process based upon tooling andenergy requirements, the expected application requirements of the finalproduct, and the demands of the overall manufacturing process.

Referring now to FIGS. 6 a-6 b, scanning electron micrographs of abiocompatible coating including titanium on a structured surface definedby CoCrMo particles after an electrochemical test (ASTM F746) aredepicted. FIG. 6 a was acquired at ×300. FIG. 6 b was acquired at ×700.

Referring now to FIGS. 7 a-7 d, electron micrographs of a structuredsurface defined by CoCrMo particles without the biocompatible coatingafter the electrochemical test (ASTM F746) are depicted. FIG. 7 b wasacquired at ×120. FIG. 7 d was acquired at ×650.

By comparing the results shown in FIGS. 7 a-7 b with the results shownin FIGS. 6 a-6 b, it can be appreciated that the biocompatible coatingsignificantly inhibits corrosion. For example, FIGS. 7 a-7 d showsignificant evidence of intergranular corrosion attacks while FIGS. 6a-6 b do not show significant evidence of intergranular corrosionattacks.

Referring now to FIGS. 8 a-8 b, electron micrographs of a structuredsurface defined by CoCrMo particles without the biocompatible coatingbefore the electrochemical test (ASTM F746) (i.e., before any corrosiontest) are depicted. FIG. 8 a was acquired at ×120. FIG. 8 b was acquiredat ×600.

The particular material used for the substrate should be strong. Someexamples of substrate materials include ASTM F67, F75, F90, F136, F138,F560, F562, F620, F621, F799, F961, F1058, F1295, F1341, F1472, F1537,and F1586. These are all grades of titanium, CoCr, stainless steel,tantalum, or alloy(s) thereof. It is preferred that the substratematerial be a cobalt-chrome alloy. The substrate can be manufactured asa wrought, forged, or cast form.

The particular material used to define the structured surface shouldalso be strong. It is preferred that the material used to define thestructured surface be the same as the material used for the substrate(e.g., cobalt-chrome). However, the material used to define thestructured surface can be different and include any one or more of, forexample, titanium, CoCr, stainless steel, and tantalum, or alloy(s)thereof. The structured surface can be manufactured in various forms,including, but not limited to, sintered, flame sprayed, acid etched,grit blasted, cast-in, forged-in, laser textured, or micromachined form.For the manufacturing operation, it is an advantage to employ apartially sintered (porous) structure obtained by forming a layer of amixture that contains a plurality of particles and a binder, andoptionally a sacrificial filler.

For non-interconnecting (nonporous) structures, the surface roughness(R_(a) or R₂) of the structured surface can range from approximately 100to approximately 40,000 μ/inch, preferably from approximately 3,000 toapproximately 30,000 μ/inch. When the structured surface is defined by aporous layer, the layer can have a thickness from approximately 0.010 to0.080 inch deep, preferably from approximately 0.010 to 0.060 inch deep.In the case of porous structures, the pore sizes can be fromapproximately 50 to approximately 500 microns, preferably fromapproximately 200 to 450 microns.

The particular material used for the coating should be biocompatible andprovide a suitable surface for tissue in-growth and/or on-growth. It ispreferred that the coating be titanium. However, the coating can includeone or more of, for example, titanium, tantalum, calcium phosphate,hydroxyapatite, and tissue in-growth and/or on-growth promotingproteins, or alloys thereof.

When the thickness of the coating is excessively thin, parts of thestructured surface may not be covered. On the other hand, when thethickness of the coating is excessively high, the strength of thecoating may go down due to residual, thermal induced stress. For thespecific embodiment of pure titanium on a structured surface defined bya sintered plurality of particles with interconnected porosity, in thedeepest region (e.g., bottom of the lowest pore), the minimum coatingthickness can be approximately 1 micron. In the outermost region (e.g.,top of the highest particle), the maximum coating thickness can beapproximately 20 microns.

However, the particular materials selected for coating and substrate arenot essential to the invention, as long as they provide the describedfunctions. Normally, those who make or use the invention will select thebest commercially available materials based upon the economics of costand availability, the expected specific application requirements of thefinal product, and the demands of the overall manufacturing process.

The disclosed embodiments show a continuous coating deposited in one ormore zones across at least a portion of a structured surface as thestructure for performing the function of facilitating tissue in-growthand/or on-growth. However, the structure for promoting tissue in-growthand/or on-growth can be any other structure capable of performing thefunction of achieving tissue adhesion, including, by way of example, apattern such as an array of dots, or lines, or any other geometricpattern.

While not being limited to any particular performance indicator ordiagnostic identifier, preferred embodiments of the invention can beidentified one at a time by testing for the presence of high adhesionbetween the coating and the structured surface. The test for thepresence of high adhesion can be carried out without undueexperimentation by the use of simple and conventional tribological andmechanical experiments. Among the other ways in which to seekembodiments having the attribute of high adhesion guidance toward thenext preferred embodiment can be based on the presence of high coatingcoverage of undercut surfaces (e.g., hidden interconnected pores). Thetest for the presence of high coating coverage of undercut surfaces canbe carried out without undue experimentation by the use of simple andconventional optical and/or electron microscope imaging techniques.

PRACTICAL APPLICATIONS OF THE INVENTION

A practical application of the invention that has value within thetechnological arts is the fabrication of an implant for the replacementof a knee joint or a hip joint. Further, the invention is useful inconjunction with other implants (such as pins used for the purpose ofjoining bones), or the like. There are virtually innumerable uses forthe invention, all of which need not be detailed here.

ADVANTAGES OF THE INVENTION

An implant, representing an embodiment of the invention, can be costeffective and advantageous for at least the following reasons. Theimplants are simple and economical to implement. The implants haveincreased strength due to the structured surface being defined by a highstrength material and better biocompatibility due to the use ofmaterials for the coating that are more biocompatible than thesubstrate. A single implant can possess different surface areas that areindividually optimized with i) some areas bearing tissue in-growthand/or on-growth composite coating, ii) some areas exhibiting theproperties of the substrate material(s), and iii) some areas bearinghard surfaces formed by treatments, such as, for example, ionbombardment.

All the disclosed embodiments of the invention described herein can berealized and practiced without undue experimentation. Although the bestmode of carrying out the invention contemplated by the inventors isdisclosed above, practice of the invention is not limited thereto.Accordingly, it will be appreciated by those skilled in the art that theinvention may be practiced otherwise than as specifically describedherein.

For example, the individual components need not be formed in thedisclosed shapes, or assembled in the disclosed configuration, but couldbe provided in virtually any shape, and assembled in virtually anyconfiguration. Further, the individual components need not be fabricatedfrom the disclosed materials, but could be fabricated from virtually anysuitable materials. Further, although the implant described herein is aphysically separate module, it will be manifest that the implant may beintegrated into additional apparatus with which it is associated.Furthermore, all the disclosed elements and features of each disclosedembodiment can be combined with or substituted for, the disclosedelements and features of every other disclosed embodiment except wheresuch elements or features are mutually exclusive.

It will be manifest that various additions, modifications andrearrangements of the features of the invention may be made withoutdeviating from the spirit and scope of the underlying inventive concept.It is intended that the scope of the invention as defined by theappended claims and their equivalents cover all such additions,modifications, and rearrangements. The appended claims are not to beinterpreted as including means-plus-function limitations, unless such alimitation is explicitly recited in a given claim using the phrase“means-for.” Expedient embodiments of the invention are differentiatedby the appended subclaims.

1. An osteoconductive process comprising: providing an implantcomprising: a substrate; a structured surface formed on at least aportion of the substrate, the structured surface being of the samematerial as the substrate; and a biocompatible coating deposited by aselected one of (i) arc evaporation physical vapor deposition and (ii)chemical vapor deposition on at least a fraction of the structuredsurface, the coating being softer and more biocompatible than thesubstrate and the structured surface; testing for the presence of highadhesion between the coating and the structured surface; and contactinga bone under in vivo conditions with the implant.
 2. An osteoconductiveprocess-comprising: providing a composition for an implant, thecomposition comprising a biocompatible material coated by a selected oneof (i) arc evaporation physical vapor deposition and (ii) chemical vapordeposition on a structured surface defined by a substrate, the coatingbeing softer and more biocompatible than the substrate and thestructured surface; testing for the presence of high adhesion betweenthe coating and the structured surface, and contacting a bone under invivo conditions with the composition.
 3. A method for orthopedic surgerywhich comprises: providing an implant comprising: a substrate; astructured surface formed on a portion of the substrate, the structuredsurface being of the same material as the substrate; and a biocompatiblecoating deposited by a selected one of (i) arc evaporation physicalvapor deposition and (ii) chemical vapor deposition on at least afraction of the structured surface, the coating being softer and morebiocompatible than the substrate and the structured surface; testing forthe presence of high adhesion between the coating and the structuredsurface; and contacting a bone under in vivo conditions with theimplant; wherein the portion of the substrate is fixed with at least oneof tissue in-growth and tissue on-growth for stability.
 4. Anosteoconductive process comprising: providing an implant, the implantcomprising: a substrate; a structured surface formed on a portion of thesubstrate, the structured surface being of the same material as thesubstrate; and a biocompatible coating deposited by a selected one of(i) arc evaporation physical vapor deposition and (ii) chemical vapordeposition on at least a fraction of the structured surface, the coatingbeing softer and more biocompatible than the substrate and thestructured surface; testing for the presence of high adhesion betweenthe coating and the structured surface; and contacting a bone under invivo conditions with the implant; wherein the portion of the substrateis fixed with a selected one of tissue in-growth and tissue on-growthfor stability.
 5. A method of forming a composite coating, the methodcomprising: depositing a biocompatible coating on a structured surfacethat comprises at least a portion of a surface area of a substrate;wherein depositing the biocompatible coating includes depositing acoating that is more biocompatible than the structured surface; whereindepositing the biocompatible coating includes depositing a coating thatis softer than the structured surface.
 6. The method of forming acomposite coating according to claim 5, further comprising: covering theportion of the surface area of the substrate with a mixture including aplurality of particles, the plurality of particles including a firstmaterial; and sintering the plurality of particles to produce a porousstructure; wherein the biocompatible coating includes a second materialthat is different from the first material.
 7. The method of claim 5,wherein depositing the biocompatible coating includes depositing acoating that is more biocompatible than the substrate.
 8. The method ofclaim 5, wherein depositing the biocompatible coating includesdepositing a coating that is softer than the substrate.
 9. The method ofclaim 5, wherein the depositing of the biocompatible coating includesforming the biocompatible coating by a thin film technique.
 10. Themethod of claim 9, wherein the thin film technique includes at least onedeposition process selected from the group consisting of physical vapordeposition and chemical vapor deposition.
 11. The method of claim 5,further comprising, before the step of depositing the biocompatiblecoating, forming a plurality of undercuts in the structured surface, andwherein depositing the biocompatible coating includes coating theplurality of undercuts in the structured surface.
 12. The method ofclaim 11, wherein forming a plurality of undercuts includes forminginterconnected pores beneath the structured surface, and whereindepositing the biocompatible coating includes coating the interconnectedpores.
 13. The method of claim 5, further comprising, before the step ofdepositing a biocompatible coating, providing the substrate with atleast one material selected from the group consisting ofcarbon-composite, stainless steel, cobalt-chromium, titanium alloy,tantalum, and ceramic.
 14. The method of claim 5, further comprising,before the step of depositing a biocompatible coating, providing thestructured surface with a material that includes a plurality ofparticles that are sintered together to form a continuous porous phase.15. The method of claim 5, further comprising, before the step ofdepositing a biocompatible coating, preparing the structured surface byat least one method selected from the group consisting of sintering,flame spraying, acid etching, grit blasting, casting-in, forging-in,laser texturing, and micromachining.
 16. The method of claim 5, whereindepositing the biocompatible coating includes depositing at least onematerial selected from the group consisting of titanium, tantalum,carbon, calcium phosphate, zirconium, niobium, hafnium, hydroxyapatite,and tissue in-growth and/or on-growth facilitating proteins.
 17. Themethod of claim 5, wherein depositing the biocompatible coating includesdepositing multi-layers.
 18. The method of claim 17, wherein depositingthe biocompatible coating includes depositing nano-layers.
 19. Themethod of claim 5, further comprising, after the step of depositing abiocompatible coating, treating another portion of the surface area withion bombardment.